Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000188336
Ethics application status
Approved
Date submitted
7/04/2008
Date registered
11/04/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Mental Health First Aid Educational Materials - a Randomised Controlled Trial
Scientific title
An evaluation of the effects of mental health first aid training in a community sample of adults by e-learning CD-ROM compared to either a printed manual or no training and the impact on mental health literacy, confidence in providing first aid, stigmatizing attitudes and first aid actions taken to help people with mental health problems.
Secondary ID [1] 252373 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health literacy 3012 0
confidence in providing mental health first aid 3013 0
stigmatizing attitudes 3014 0
number of first aid actions taken to help people with mental health problems 3015 0
first-aider mental health 257887 0
Condition category
Condition code
Mental Health 3163 3163 0 0
Depression
Mental Health 3164 3164 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 hour e-learning CD ROM on Mental Health First Aid (MHFA) or hard-copy MHFA manual or Wait List control. Completion of 3 online surveys (prior to receiving intervention, post intervention and at six-month follow-up).
Intervention code [1] 2753 0
Prevention
Comparator / control treatment
Wait List
Control group
Active

Outcomes
Primary outcome [1] 4047 0
mental health literacy. This is measured using some of the questions from the National Survey of Mental Health Literacy.
Timepoint [1] 4047 0
Completion of three online surveys (pre-study, post intervention and six month follow-up) to determine changes in knowledge, attitudes and helping behaviour towards people with mental health problems.
Primary outcome [2] 259353 0
Confidence in providing mental health first aid. This was measured by including a questionnaire item which asked participants how confident they would feel in helping a person in a vignette depicting depression (Mary), and another person in a vignette depicting schizophrenia (John). Each were rated on a 5-point scale (1 = Not at all, 2 = A little bit, 3 = Moderately, 4 = Quite a bit and 5 = Extremely).
Timepoint [2] 259353 0
at baseline, 1-month post intervention and 6-months follow-up.
Primary outcome [3] 259354 0
Number of helping behaviours towards people with mental health problems. This was measured including a questionnaire item which asked how often a participant had talked to a person about their mental health problem over the past 6-months. This was rated using a 4-point scale (1 = never, 2 = once, 3 = a few times and 4 = many times). If a participant indicated they had spoken to someone, they were asked to indicate which of the following they had done (multiple responses were allowed): 1) Spent time listening to their problem; 2) Helped to calm them down; 3) Talked to them about suicidal thoughts; 4) Recommended they seek professional help; 5) Recommended self-help strategies; 6) Gave them information about their problem; 7) Gave them information about local services; 8) Made an appointment for them with services; 9) Referred them to books or websites about their problem or 10) other (open-ended response). Scoring was based on 1 point per action taken and totals were converted into percentages.
Timepoint [3] 259354 0
at baseline and 6-months follow-up.
Secondary outcome [1] 6810 0
stigmatizing attitudes. This is measured using the Social Distance Scale. Also, the Personal and Perceived Stigma Scales will be used.
Timepoint [1] 6810 0
Completion of three online surveys (pre-study, post intervention and six month follow-up) to determine changes in knowledge, attitudes and helping behaviour towards people with mental health problems.
Secondary outcome [2] 265835 0
first-aider mental health, using the Kessler Psychological Distress Scale (K-10+). This is a 10-item self-report measure of psychological distress in the past month, using a 5-point scale (1 = None of the time , 2 = A little of the time, 3 = Some of the time, 4 = Most of the time, 5 = All of the time). The following questionnaire item was included: ?Over the last 30 days, how often did you feel: a) tired out for no good reason? b) nervous? c) so nervous that nothing could calm you down? d) hopeless? e) restless or fidgety? f) so restless that you could not sit still? g) depressed? h) so depressed that nothing could cheer you up? i) that everything was an effort? j) worthless?? Scores were summed and ranged between 10-50, with scores above 19 indicating higher distress.
Timepoint [2] 265835 0
at baseline, 1-month post intervention and 6-months follow-up.

Eligibility
Key inclusion criteria
computer with a CD drive and internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
no computer or internet access
unable to read English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Research Plan is designed to meet the requirements of the CONSORT checklist. Adult members of the general public will be recruited through publicity in newspapers and public noticeboards, primarily from metropolitan Melbourne. Potential participants will contact the Research Assistant via telephone or email and will be emailed a Participant Information Sheet and Consent Form. Once the latter is returned, a unique ID will be generated in Excel and emailed individually to participants, along with a link to the pre-study online questionnaire. On completion of the first questionnaire, the unique ID numbers will be given to Prof A Jorm, who without knowledge of participant details, will use the Random Integers option (Random.org) to generate a randomly assigned variable (values of 1-3) to determine which condition they are allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prof A Jorm will use the Random Integers option at (Random.org) to generate a value between 1 to 3 (1 = e-learning CD ROM; 2 = printed manual and 3 = added to Wait List). These will be recorded next to the the participants' uinique ID number (with no other information) and returned to the Research Assistant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 811 0
3040
Recruitment postcode(s) [2] 812 0
3052
Recruitment postcode(s) [3] 813 0
3000

Funding & Sponsors
Funding source category [1] 3272 0
Charities/Societies/Foundations
Name [1] 3272 0
Australian Rotary Health Research Fund
Country [1] 3272 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
ORYGEN Research Centre
35 Poplar Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 2926 0
Charities/Societies/Foundations
Name [1] 2926 0
Australian Rotary Health Research Fund
Address [1] 2926 0
Australian Rotary Health Research Fund
Floor 2
Rotary Down Under House
43 Hunter Street
PARRAMATTA NSW 2150
Country [1] 2926 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5257 0
The University of Melbourne Human Ethics Advisory Group
Ethics committee address [1] 5257 0
Ethics committee country [1] 5257 0
Australia
Date submitted for ethics approval [1] 5257 0
17/04/2008
Approval date [1] 5257 0
Ethics approval number [1] 5257 0
0827110

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28503 0
Address 28503 0
Country 28503 0
Phone 28503 0
Fax 28503 0
Email 28503 0
Contact person for public queries
Name 11660 0
Julie-Anne Fischer
Address 11660 0
ORYGEN Research Centre
35 Poplar Road
PARKVILLE VIC 3052
Country 11660 0
Australia
Phone 11660 0
+ 61 3 9342 3768
Fax 11660 0
Email 11660 0
[email protected]
Contact person for scientific queries
Name 2588 0
Professor Anthony F Jorm
Address 2588 0
ORYGEN Research Centre
35 Poplar Road
PARKVILLE VIC 3052
Country 2588 0
Australia
Phone 2588 0
+ 61 3 9342 3747
Fax 2588 0
Email 2588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.